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NCT02924766 · ClinicalTrials.gov registry record · Phase 1

A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

A Phase 1 study of Prostatic Neoplasms, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target
6
Study locations

NCT02924766 is a Phase 1 study of Prostatic Neoplasms that has completed, run by Janssen Research & Development. The registered enrollment target is 34 participants, below the 514-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT02924766, a Phase 1 study of Prostatic Neoplasms, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target
6
Study locations

Study Summary

The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.

Conditions Studied

Prostatic Neoplasms

Interventions

  • DRUG Apalutamide
  • DRUG Prednisone
  • DRUG Abiraterone Acetate
  • DRUG Niraparib

Study Locations (6)

California

  • - West Hollywood

Kentucky

  • - Louisville

Oregon

  • - Portland

South Carolina

  • - Myrtle Beach

British Columbia

  • - Vancouver

Quebec

  • - Montreal

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2016-10-03
Est. Completion 2019-07-19
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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What the Registry Record Tells You About NCT02924766

The ClinicalTrials.gov registry entry for NCT02924766 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 514-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (93% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Apalutamide is the first listed.

NCT02924766 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Kentucky, Oregon.

Frequently Asked Questions

What is clinical trial NCT02924766 about?

NCT02924766 is a clinical study titled "A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)". The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may ...

What is the current status of trial NCT02924766?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2016-10-03. Estimated completion is 2019-07-19.

What conditions does trial NCT02924766 study?

This clinical trial studies the following conditions: Prostatic Neoplasms.

What interventions are being tested in trial NCT02924766?

The interventions under investigation include: Apalutamide (DRUG), Prednisone (DRUG), Abiraterone Acetate (DRUG), Niraparib (DRUG).

Who is sponsoring clinical trial NCT02924766?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02924766 being conducted?

This trial has 6 study locations across California, Kentucky, Oregon, South Carolina, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.